Packaging and storage
Preserve in tight, light-resistant containers, and store in a cool, dry place.
Residue on ignition 281
Evaporate 10 mL in a suitable crucible, and ignite to constant weight: the limit is 0.005%.
Chlorinated compounds
Wind a 1.5- × 5-cm strip of 20-mesh copper gauze around the end of a copper wire. Heat the gauze in the nonluminous flame of a Bunsen burner until it glows without coloring the flame green. Permit the gauze to cool, and heat several times until a good coat of oxide has formed. Apply with a medicine dropper 2 drops of Phenylethyl Alcohol to the cooled gauze, ignite, and permit it to burn freely in the air. Again cool the gauze, add 2 more drops of Phenylethyl Alcohol, and burn as before. Continue this process until a total of 6 drops has been added and ignited, and then hold the gauze in the outer edge of the Bunsen flame, adjusted to a height of about 4 cm: no transient green color or other color is imparted to the flame.
Aldehyde
Shake 5 mL with 5 mL of 1 N sodium hydroxide, and allow to stand for 1 hour: no yellow color appears in the organic (top) layer.
Organic volatile impurities, Method IV 467:
meets the requirements.
Auxiliary Information
Staff Liaison :
Catherine Sheehan, B.Sc., Scientist
Expert Committee : (EM105) Excipient Monographs 1
USP29NF24 Page 1714
Pharmacopeial Forum : Volume No. 30(4) Page 1290
Phone Number : 1-301-816-8262